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2007-09-06 12:55:00 CEST 2008-01-17 12:56:31 CET REGLERAD INFORMATION Inion Oyj - Company AnnouncementInion Announces Results of its Proof of Principle Clinical Study Evaluating the Ability of Inion OptimaPLUS™ Bioactive Material to Accelerate Bone Growth Following SurgeryInion Announces Results of its Proof of Principle Clinical Study Evaluating the Ability of Inion OptimaPLUS™ Bioactive Material to Accelerate Bone Growth Following Surgery Tampere, Finland and Guildford, UK. 6 September 2007…Inion [LSE: IIN.L], a company focused on the development of novel biodegradable medical implants, announces that results of the first of its two pilot clinical proof of principle studies with Inion OptimaPLUS™ bioactive material, have proved inconclusive with respect to its ability to accelerate bone growth, compared to the state of the art guided bone regeneration membrane. The second proof of principle interim clinical trial results, evaluating bone quality following the use of Inion OptimaPLUS™ in a different surgical model, will be announced in October 2007. The results were deemed inconclusive as the accelerated bone growth trial was stopped prematurely following five patients experiencing inflammatory events in the Hong Kong arm of the trial. These events do not appear to be related to the Inion OptimaPLUS™ bioactive material as surgical controls in the Hong Kong arm also experienced the same inflammatory events. Furthermore, no similar events were observed at the second trial site in Zurich, Switzerland. The reduction in the total number of evaluable patients included in the trial, however, means that it has not been possible to complete the study or to generate efficacy results that are statistically significant. The trial, which began in Q4 2006, aimed to recruit 20 patients across two centres in Hong Kong and in Zurich. The study was designed to evaluate a number of measures of bone growth following the use of Inion OptimaPLUS™ after wisdom tooth extraction. Previous preclinical studies have shown the active ingredient in Inion OptimaPLUS™, N-methyl-pyrrolidone (NMP), can increase the rate of bone growth significantly compared to surgical controls. Inion is conducting a thorough evaluation of the trial and all results generated to date in order to better understand the different experiences observed at the two sites. As noted above, the Company is also undertaking a clinical trial evaluating the quality of new bone growth resulting from the use of Inion OptimaPLUS™ in a different surgical model involving dental implants. The interim results from this bone quality trial, expected in October, together with the full evaluation of the first trial to assess accelerated bone growth, will inform the Company's decision on how to proceed with the clinical programme for Inion OptimaPLUS™. Chris Lee, Inion's CEO said: “Inion is committed to properly assessing the potential of the bioactive compound NMP, as a component in Inion OptimaPLUS™ medical implants, to accelerate bone growth following surgery. While the results we have seen to date have proved inconclusive, we will conduct a full evaluation of the trial and data collected so far to determine whether NMP can reproduce in the clinic the accelerated bone growth we have seen in preclinical trials. This, together with the results of our ongoing bone quality trial, will provide important input into our decision about the next steps of the clinical programme for Inion OptimaPLUS™.” - Ends - For further information, please contact: -------------------------------------------------------------------------------- | Inion Oy | Tel: +44 (0)1483 685390 | | Chris Lee, Chief Executive | | | Officer | | | Julien Cotta, Chief Financial Officer | | -------------------------------------------------------------------------------- | Citigate Dewe Rogerson | Tel: +44 (0)207 638 9571 | | Mark Swallow / David | Mob: +44 (0)7903 737703 | | Dible / Helena Galilee | | -------------------------------------------------------------------------------- About Inion (www.inion.com) Inion Oy is a medical devices company focused on the development and successful commercialisation of innovative biodegradable and bioactive implants in key target markets. The Company's target segments are Spine and Specialty Orthopaedics. Inion's core expertise and technology lies in the design and manufacture of innovative biodegradable plates, screws, pins and membranes, which are used to enhance the healing of bone or soft tissue injuries to the skeleton, such as those caused by trauma or by reconstructive surgery. Inion implants are made from its proprietary Inion Optima™ family of biomaterials, with properties tailored for specific surgical applications, in terms of strength, flexibility and rate of degradation. Inion is also focused on developing proprietary new bioactive and biodegradable biomaterials that promote bone healing and accelerate patient rehabilitation. Inion was incorporated in early 2000 and listed on the Official List of the UK Listing Authority in December 2004. The Company has an office and an R&D facility in the UK and head office, R&D and production facilities in Tampere, Finland. This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Inion's funding requirements, regulatory approvals, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statement. |
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